Katie Bond is a partner, and Samuel A. Butler is an associate, in the Washington, DC office of Keller and Heckman LLP.

It’s not every day that a Supreme Court denial of a petition for certiorari brings to mind folk wisdom about ensuring good luck in a marriage, but sometimes the rhyme just fits too well to ignore! A First Circuit decision from last year on FDCA preemption, disease claims, and DSHEA disclaimers will not make it to the high court, leaving in place a marriage between the First, Eighth and Ninth Circuits on their test for such preemption.

Something old: it’s long been the law in the Eighth and Ninth Circuits that a state-law claim is preempted by the Food, Drug, and Cosmetic Act unless (1) the alleged conduct violates the FDCA but (2) that violation is not the basis of the lawsuit. That’s because, if the conduct is permitted by the FDCA, a state law cannot prohibit it. However, the FDCA contains no private right of action, so a plaintiff cannot sue simply based on allegations that conduct violates the FDCA.

Something new: Earlier this month the Supreme Court declined to review a First Circuit decision affirming dismissal of a putative class action based significantly on preemption of this sort.

Something borrowed: The First Circuit’s decision applied the test described above, initially borrowed from the Eighth and Ninth Circuits for the food-labeling context in a 2019 decision.

Something blue: The products at issue were Lactaid’s Fast Act Chewables, Fast Act Caplets, and Original Strength Caplets, each of which comes in blue packaging.

Interestingly, preemption played almost no role in the trial court’s decision granting the motion to dismiss by McNeil Nutritionals, the manufacturer of the Lactaid products. The decision noted McNeil’s preemption argument but focused on the alleged deceptiveness of Lactaid’s advertising under state law. The plaintiff alleged that Lactaid made an impermissible disease claim regarding managing lactose intolerance. As a result, its label was deceptive because either (1) supplements can’t treat diseases, or (2) it can treat a disease, and so is a drug, contrary to its label statements that it is a supplement. The trial court focused on the standard DSHEA disclaimers used on the front and back of the packaging to determine that the plaintiff failed to allege that any of the label claims were deceptive.

The appellate court shifted gears entirely and focused on the preemption argument. In particular, it discussed a 2001 Supreme Court decision holding that a claim based on allegedly deceiving the FDA is preempted by the federal statutory scheme according the FDA sole authority to enforce the FDCA. The First Circuit held that the two-part preemption test described above answered well to this understanding of preemption. A “plaintiff must be suing for conduct that violates the FDCA …, but the plaintiff must not be suing because the conduct violates the FDCA.” DiCroce could not meet this test because her allegations of deceptiveness were based only on violations of the FDCA.

DiCroce’s certiorari petition asked the Supreme Court to review the preemption test adopted by the First, Eighth, and Ninth Circuits. In particular, the petition attempts to draw a distinction between a prohibition on claims based only on a violation of the FDCA and her claim, which she characterized as fundamentally based on a deception of consumers.

And so far as that goes, that seems reasonable enough. The petition does not, however, provide any real argument to respond to the trial court’s determination that DiCroce failed to adequately allege deception in violation of applicable state law. As above, the First Circuit presented its decision as fundamentally continuous with precedent that has existed in other circuits since 2010 and in the First Circuit since 2019. While a denial of certiorari is not anything like an approval of the precedent at issue, it does provide additional ammunition for litigants arguing for the adoption of the two-part test in other circuits.